Keynote 155

For patients with relapsed/refractory chronic lymphocytic leukemia, multiple myeloma or diffuse large B-cell lymphoma

Study of Pembrolizumab in Combination With Dinaciclib in Hematologic Malignancies

This is a non-randomized, open-label study evaluating the safety and efficacy of pembrolizumab (MK-3475) used in combination with dinaciclib (MK-7965) in the treatment of relapsed or refractory chronic lymphocytic leukemia (rrCLL), multiple myeloma (rrMM), or diffuse large B-cell lymphoma (rrDLBCL) in up to 138 participants from multiple sites. During an initial Dose Evaluation phase (first 2 cycles) to determine Dose Limiting Toxicities (DLTs), dose combinations of pembrolizumab 200 mg followed by dinaciclib 7 mg/m^2, pembrolizumab 200 mg followed by dinaciclib 10 mg/m^2, and pembrolizumab 200 mg followed by dinaciclib 14 mg/m^2 will be evaluated. Following safety review of the Dose Evaluation Phase, approximately 30 participants each will be enrolled in rrCLL, rrMM, or DLBCL cohorts during the Signal Detection phase. For each disease type objective response rate (ORR) will be determined by disease specific criteria.

Status:

Recruiting

Phase 1 Icon

Trial Phase

The investigational immunotherapy is being studied in a small group of patients for the first time to evaluate its safety, determine a safe dosage range and identify side effects.

Eligibility

About the Trial

All patients who enroll in the trial will receive medication while on the study.

  • 100% will receive pembrolizumab along with dinaciclib


Trial Purpose
14

US Trial Locations

Clinical trial sites are places such as hospitals or clinics where the trial is being conducted.

See Locations

National Trial Reference Number

NCT02684617 Read More at clinicaltrials.gov

What Can You Do Next?

If you would like to learn about this clinical trial or see if you can participate, you can:

Contact Our Trial Info Center

To learn more, call 1-888-577-8839

Discuss With Your Doctor

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Tip: To help with understanding of some clinical terms used on the page, select an underlined term to see what they mean.

Eligibility

Only a qualified healthcare professional can determine your eligibility. However, this information may be useful in starting a conversation with your doctor.

Condition

The disease, disorder, syndrome, illness, or injury that is being studied. Conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • rrCLL
  • rrMM
  • rrDLBCL

Age range

18 — no age maximum

Gender(s)

All

Trial Purpose

This is a non-randomized, open-label study evaluating the safety and efficacy of pembrolizumab (MK-3475) used in combination with dinaciclib (MK-7965) in the treatment of relapsed or refractory chronic lymphocytic leukemia (rrCLL), multiple myeloma (rrMM), or diffuse large B-cell lymphoma (rrDLBCL) in up to 138 participants from multiple sites. During an initial Dose Evaluation phase (first 2 cycles) to determine Dose Limiting Toxicities (DLTs), dose combinations of pembrolizumab 200 mg followed by dinaciclib 7 mg/m^2, pembrolizumab 200 mg followed by dinaciclib 10 mg/m^2, and pembrolizumab 200 mg followed by dinaciclib 14 mg/m^2 will be evaluated. Following safety review of the Dose Evaluation Phase, approximately 30 participants each will be enrolled in rrCLL, rrMM, or DLBCL cohorts during the Signal Detection phase. For each disease type objective response rate (ORR) will be determined by disease specific criteria.

Important information

Participating in a clinical trial is an important decision. Anyone participating in a trial should know as much as possible about what is being studied, what risks are involved and what potential benefits may be gained before deciding to enroll. If you are interested in participating in a clinical trial, please talk to your doctor first.

Trial Locations

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    Location
    Status
  • Detroit, Michigan, United States, 48202
    Recruiting
  • Duarte, California, United States, 91010
    Recruiting
  • Columbus, Ohio, United States, 43210
    Recruiting
  • Hershey, Pennsylvania, United States, 17033
    Recruiting
  • Seattle, Washington, United States, 98116
    Recruiting
  • Detroit, Michigan, United States, 48201
    Recruiting
  • Boston, Massachusetts, United States, 02111
    Recruiting
  • Rochester, Minnesota, United States, 55905
    Recruiting
  • Madison, Wisconsin, United States, 53792
    Recruiting
  • New Orleans, Louisiana, United States, 70121
    Recruiting
  • Dallas, Texas, United States, 75246
    Recruiting
  • Buffalo, New York, United States, 14263
    Recruiting
  • New Brunswick, New Jersey, United States, 08903-2681
    Recruiting
  • Los Angeles, California, United States, 90033
    Recruiting

How to Learn More

When speaking to your doctor, please have the trial reference number available. You can also call 1-888-577-8839 for more information.

Print or email this page.

Trial reference number

A unique identification code given to each clinical trial registered on clinicaltrials.gov.

Keynote number

A unique identification code used by the sponsor to identify a specific trial.
Keynote-155

Official title

A description of the clinical trial that the trial sponsor and clinicians use to identify a specific trial and its purpose.
Phase Ib Trial of Pembrolizumab (MK-3475) in Combination With Dinaciclib (MK-7965) in Subjects With Hematologic Malignancies (KEYNOTE-155).
keynote 155 trial logo

Call 1-888-577-8839 to contact our trial information center

Clinical Trials: Important Information to Consider

There is a lot to consider when deciding whether to participate in a clinical study. Any clinical study includes risks, which the study doctor will review with you. Make sure you understand the risks before participating.